Archimedes Pharma Launches Lazanda® - the Only Fentanyl Nasal Spray for the Management of Breakthrough Pain in Cancer in the U.S.

contraindicated in opioid non-tolerant patients and is contraindicated in the management of acute or postoperative pain including headache/migraine dental pain or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products. When prescribin

contraindicated in opioid non-tolerant patients and is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products. When prescribing, do not convert patients on a mcg per mcg basis from another fentanyl product to Lazanda. Patients beginning treatment with Lazanda must begin with titration from the 100 mcg dose. (see Dosage and Administration) When dispensing, do not substitute a Lazanda prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetics of Lazanda compared to other fentanyl products that could result in clinically important differences in the rate and extent of absorption of fentanyl and could result in fatal overdose. Special care must be used when dosing with Lazanda. If the breakthrough pain episode is not relieved, patients must wait at least 2 hours before taking another dose ofLazanda. (see Dosage and Administration)Lazanda is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.Patients and their caregivers must be instructed that Lazanda contains a medicine in an amount that can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. Lazanda must be kept out of the reach of children at all times. (see Patient/Caregiver Instructions) The concomitant use of Lazanda with cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.Because of the risk for misuse, abuse, addiction, and overdose, Lazanda is availabl'/>"/>

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